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Date Added: Wed 02/12/2020

Head Of Regulatory Affairs

County Galway, Ireland
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Job Type: Permanent

Salary: €90000 - €100000 / annually

Basic summary: 

  • To Manage the Veterinary Regulatory affairs team and to achieve new marketing authorisations and maintain existing Marketing Authorisations in an efficient manner in line with company strategy. To act as the qualified person for pharmacovigilance (QPPV) for veterinary products.

Essential duties and responsibilities:

  • The functions of the Veterinary Regulatory Affairs Manager include but are not limited to the following:-
  • Maintain Existing Marketing Authorisations World-Wide
  • Design product-specific regulatory programmes and agree priorities and time schedules in conjunction with the management team
  • Organise and lead the submission and approval of new products via national, mutual recognition, decentralised and centralised procedures
  • Organise and co-ordinate appropriate resources to meet the demands of the Regulatory Programme as agreed with Managing Director/senior management team
  • Manage Veterinary Regulatory affairs team and provide advice to R&D in relation to regulatory requirements for veterinary products
  • Identification and Out-sourcing of Animal Studies to Good Laboratory Practice (GLP)
  • Identification and Out-sourcing of Animal Studies to Good Clinical Practice (GCP) approved sites
  • Protocol design for Clinical / Bioequivalence / Tolerance studies
  • Communication with study directors responsible for out-sourced trial work
  • Liaise with regulatory bodies within Europe and with appointed agents in other countries
  • Negotiate win/win situations with regulatory bodies on issues that arise during assessment.
  • Review regulatory issues in Contracts, Secrecy Agreements and Sales and Distribution Agreements
  • Keep up to date with changes in global regulatory requirements
  • Maintaining veterinary pharmacovigilance system
  • Conducting continuous overall pharmacovigilance evaluation during the post authorisation period of products
  • Managing of the provision to the NCAs or the Agency of any other information relevant to the evaluation of the benefits and risks of a VMP
  • Managing the Preparation of Periodic Safety Update Reports for submission to Regulatory authorities in relation to national, MRP, DCP and centrally approved Marketing Authorisations
  • Managing the maintenance of Pharmacovigilance systems (CRF's PSUR data base, Line Listings)

Competencies: 

  • Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication skills.
  • Ability to lead a team and manage diverse personalities and viewpoints. 
  • Ability to build relationships and collaborate with others is vital.
  • Strategic decision-making within the business as an influencer. 
  • Being able to understand company finances, resourcing and ultimate aims of the business is important role-modelling.
  • A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
  • Proven people management capabilities. Ability to motivate a team and collaborate cross-functional and across geographies
  • Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
  • Positive and proactive person who is energised by having great responsibility
  • Practical, action-orientated approach to managing priorities and teams.
  • Strong computer skills in MS Office

Qualifications:

  • Scientific qualification and background preferably B.Sc. or equivalent.
  • Minimum 8 years in a FDA/CVM regulatory/R&D environment preferably with experience of generic applications. Kn
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